Federal Register / Vol. 89, No. 246 / Monday, December 23, 2024 / Notices 104549 

established additional burden 

associated with §§ 494.70(c) and 

494.180(k); these were quantified in the 

preceding information collection which 

expired in 2024 (OMB Control Number 

0938–0386). Since these regulations 

were not finalized due to litigation, they 

are no longer in effect. Therefore, we 

took out these sections from this 

package as they do not impose any 

burden. 

An additional revision to the ESRD 

CfCs at 42 CFR 494 was precipitated by 

final rule, ‘‘Medicare and Medicaid 

Programs; Emergency Preparedness 

Requirements for Medicare and 

Medicaid Participating Providers and 

Suppliers,’’ published September 16, 

2016 (CMS–3178–F). This rule 

established the creation and 

maintenance of an Emergency 

Preparedness Plan at 494.62(a), an 

Emergency Preparedness Policies and 

Procedures document at 494.62(b), an 

Emergency Preparedness 

Communication Plan at 494.62(c), a 

training program 494.62(d), and 

documentation of training exercises 

494.62(e). These information collections 

are in separate package, OMB Control 

number 0938–1325. 

On July 5, 2024, revisions to the CfC 

were proposed in ‘‘Medicare Program; 

End-Stage Renal Disease Prospective 

Payment System, Payment for Renal 

Dialysis Services Furnished to 

Individuals with Acute Kidney Injury, 

Conditions for Coverage for End-Stage 

Renal Disease Facilities, End-Stage 

Renal Disease Quality Incentive 

Program, and End-Stage Renal Disease 

Treatment Choices Model’’, (CMS– 

1805–P). This rule proposed to expand 

coverage of home dialysis services to 

patients with acute kidney injury (AKI). 

Since the ESRD CfCs apply to dialysis 

facilities, not to people with ESRD, this 

rule proposes to revise language in the 

CfCs to allow beneficiaries with AKI to 

utilize home dialysis. Specifically, we 

refer to facilities abiding by the ESRD 

CfCs as ‘dialysis facilities’ opposed to 

‘ESRD facilities and all patients seeking 

services from dialysis facilities as 

‘patients’ rather than ‘ESRD patients.’ 

There is no ICR burden associated with 

these changes however we made 

confirming changes to the language in 

this package. 

The CfCs are used by Federal (CMS), 

State surveyors (employed by State 

survey agencies), or CMS authorized 

accrediting organizations as a basis for 

determining whether a dialysis facility 

qualifies for approval or re-approval 

under Medicare. Surveyors make an inperson visit to the dialysis facility to 

perform the complete survey. 

The preceding information collection, 

which expired on March 31, 2024, 

estimated the total annual hourly 

burden as 1,260,491 hours at a cost of 

$64,839,657. We revise this to 800,621 

hours at a cost of $49,638,502. The 

reduction in hours and cost is largely 

due to removing the burden estimates 

that no longer apply. Form Number: 

CMS–R–52 (OMB Control Number: 

0938–0386); Frequency: Annually; 

Affected Public: Private sector— 

Business or other for-profit; Number of 

Respondents: 8,048; Total Annual 

Responses: 215,591; Total Annual 

Hours: 800,621 (For policy questions 

regarding this collection contact Claudia 

Molinar at 410–786–8445.) 

2. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

information Collection: Expanding 

Access to Women’s Health Grant; Use: 

On March 23, 2010, President Obama 

signed into law the Patient Protection 

and Affordable Care Act (PPACA), and 

on March 30, 2010, the Health Care and 

Education Reconciliation Act of 2010 

was also signed into law (collectively 

referred to as the ‘‘ACA’’). The ACA 

includes a number of provisions that 

reform the health insurance markets and 

provide Federal consumer protections 

through amendments to title XXVII of 

the Public Health Service Act (PHS Act) 

and corresponding amendments to the 

Employee Retirement Income Security 

Act and the Internal Revenue Code. The 

ACA also includes significant grant 

funding for States to work with the 

Federal Government to implement the 

Federal market reforms and consumer 

protections. 

Section 1003 of the ACA adds a new 

section 2794 to the PHS Act entitled, 

‘‘Ensuring That Consumers Get Value 

for Their Dollars.’’ Specifically, section 

2794(a) requires the Secretary of the 

Department of Health and Human 

Services (the Secretary) (HHS), in 

conjunction with the States, to establish 

a process for the annual review of health 

insurance premiums to protect 

consumers from unreasonable rate 

increases. Section 2794(c) directs the 

Secretary to carry out a program to 

award grants to States. The data 

collection (quarterly and final reports) 

are a source of information on the 

State’s progress with meeting CMS 

expectations for the Expanding Access 

to Women’s Health Grant. The reports 

describe significant advancements 

towards the State’s goal of enhancing 

and expanding access to reproductive 

and maternal health coverage and 

services from the beginning of the grant 

period through the completion of the 

grant period. The data collection is 

imperative to CMS being able to assess 

the State’s progress, barriers, and 

updates on measurable objectives. 

Without the data collection, CMS will 

be unable to efficiently monitor the 

State’s progress. It will also inhibit 

CMS’ ability to support and share 

opportunities of best practices with 

other States. Form Number: CMS–10901 

(OMB control number 0938–NEW); 

Frequency: Quarterly; Affected Public: 

State, Local, or Tribal Governments; 

Number of Respondents: 15; Total 

Annual Responses: 68; Total Annual 

Hours: 840. (For policy questions 

regarding this collection contact Jim 

Taing at James.Taing@cms.hhs.gov.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–30502 Filed 12–20–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Statement of Organization, Functions, 

and Delegations of Authority 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA), Center for Drug 

Evaluation and Research (CDER), Office 

of Medical Policy (OMP) has modified 

their organizational structure. The new 

organizational structure was approved 

by the Secretary of Health and Human 

Services on November 19, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Wade, Acting Director, Division 

of Reorganizations and Delegations of 

Authority, Office of Budget, Office of 

Finance, Budget, and Acquisitions, 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993, 240–731–0192. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

Part D, Chapter D–B, (Food and Drug 

Administration), the Statement of 

Organization, Functions and 

Delegations of Authority for the 

Department of Health and Human 

Services (35 FR 3685, February 25, 

1970, 60 FR 56606, November 9, 1995, 

64 FR 36361, July 6, 1999, 72 FR 50112, 

August 30, 2007, 74 FR 41713, August 

18, 2009, 76 FR 45270, July 28, 2011, 

and 84 FR 22854, May 20, 2019) is 

revised to reflect the FDA’s 

reorganization of the CDER, OMP. 


khammond on DSK9W7S144PROD with NOTICES
104550 Federal Register / Vol. 89, No. 246 / Monday, December 23, 2024 / Notices 

The reorganization will improve 

FDA’s ability to carry out its public 

health mission by realigning and 

dedicating resources within the 

organization to modernize clinical trials. 

The clinical trial innovation work tracks 

will place DCI at the forefront to 

robustly meet policy development, 

implementation, and analysis needs in 

areas such as Artificial Intelligence (AI), 

Digital Health Technologies (DHTs), 

Real-World Evidence (RWE), and other 

rapidly advancing sectors in the 

dynamic clinical trial ecosystem. 

The CDER, OMP, Office of Medical 

Policy Initiatives retitled the Division of 

Clinical Trial Quality to the Division of 

Clinical Innovations. 

The reorganization will enhance the 

office’s ability to attract and retain a 

diverse workforce representative of our 

nation and bring like scientists and 

policy experts together from across the 

organization, thereby facilitating 

collaboration and efficient use of shared 

resources while advancing key 

innovations in drug development. By 

developing responsive policies, the 

Division of Clinical Innovations will 

modernize the policy environment to 

ensure that CDER is providing the 

needed regulatory perspective to guide 

the appropriate use of such tools and 

technologies. 

The FDA’s CDER, OMP has been 

restructured as follows: 

DCDH ORGANIZATION. The CDER 

OMP (DCDH) is headed by the Director, 

OMP and includes the following: 

Office of Medical Policy (DCDH) 

Office of Prescription Drug Promotion 

(DCDHA) 

Division of Advertising and Promotion 

Review II (DCDHAA) 

Division of Advertising and Promotion 

Review I (DCDHAB) 

Division of Promotion Policy, Research 

and Operations (DCDHAC) 

Office of Medical Policy Initiatives 

(DCDHB) 

Division of Medical Policy Development 

(DCDHBA) 

Division of Medical Policy Programs 

(DCDHBB) 

Division of Clinical Innovations 

(DCDHBC) 

II. Delegations of Authority 

Pending further delegation, directives, 

or orders by the Commissioner of Food 

and Drugs, all delegations and 

redelegations of authority made to 

officials and employees of affected 

organizational components will 

continue in them or their successors 

pending further redelegations, provided 

they are consistent with this 

reorganization. 

III. Electronic Access 

This reorganization is reflected in 

FDA’s Staff Manual Guide (SMG). 

Persons interested in seeing the 

complete Staff Manual Guide can find it 

on FDA’s website at: https://

www.fda.gov/AboutFDA/ 

ReportsManualsForms/ 

StaffManualGuides/default.htm. 

Authority: 44 U.S.C. 3101. 

Xavier Becerra, 

Secretary of Health and Human Services. 

[FR Doc. 2024–30333 Filed 12–20–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Council on Blood Stem Cell 

Transplantation 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Secretary’s 

Advisory Council on Blood Stem Cell 

Transplantation (ACBSCT or Council) 

has scheduled a public meeting. 

Information about ACBSCT and the 

agenda for the meeting can be found on 

the ACBSCT website at https://

bloodstemcell.hrsa.gov/about/advisorycouncil. 

DATES: Thursday, January 23, 2025, 3:00 

p.m.–5:00 p.m. Eastern Standard Time. 

ADDRESSES: This meeting will be held 

virtually by webinar. A link to register 

and join the meeting will be posted at 

least 10 days prior to the meeting at 

https://bloodstemcell.hrsa.gov/about/ 

advisory-council. 

FOR FURTHER INFORMATION CONTACT: 

Shelley Tims Grant, Designated Federal 

Official, Division of Transplantation, 

Health Systems Bureau, HRSA, 5600 

Fishers Lane, 8W–67, Rockville, 

Maryland 20857; 301–443–8036; or 

ACBSCTHRSA@hrsa.gov. 

SUPPLEMENTARY INFORMATION: ACBST 

provides advice and recommendations 

to the Secretary of HHS (Secretary) on 

policy, program development, and other 

matters of significance concerning the 

activities under the authority of 42 

U.S.C. 274k (Section 379 of the Public 

Health Service Act), Public Law 109– 

129, as amended. The Council may 

transmit its recommendations through 

the Administrator of HRSA on matters 

related to the activities of the C.W. Bill 

Young Cell Transplantation Program 

and National Cord Blood Inventory. 

The agenda for the January 23, 2025, 

meeting is being finalized and may 

include the following topics: graft 

versus host disease and late effects, 

strategies for selecting cord blood units 

for transplantation, HHS’ approach for 

reviewing the state of the science and 

recommendations on the 

appropriateness of the inclusion of adult 

stem cells and birthing tissues as new 

types of therapies in the C.W. Bill 

Young Cell Transplantation Program, 

and other areas to increase blood stem 

cell donation and transplantation. 

Agenda items are subject to change as 

priorities dictate. Refer to ACBSCT’s 

website for any updated information 

concerning the meeting. Members of the 

public will have the opportunity to 

provide comments. Public participants 

may submit written statements in 

advance of the scheduled meetings; oral 

comments will be honored in the order 

they are requested and may be limited 

as time allows. Requests to submit a 

written statement or make oral 

comments to ACBSCT should be sent to 

Shelley Tims Grant, using the contact 

information above at least 3 business 

days prior to the meeting. Individuals 

who plan to attend and need special 

assistance or other reasonable 

accommodations should notify ACBSCT 

at the address and phone number listed 

above at least 10 business days prior to 

the meeting. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2024–30604 Filed 12–20–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Request for Public Comment: 60 Day 

Notice for Extension of Fast Track 

Generic Clearance for the Collection of 

Qualitative Feedback on Agency 

Service Delivery: Indian Health Service 

Customer Service Satisfaction and 

Similar Surveys 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice and request for 

comments. Request for extension of 

approval. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, the 

Indian Health Service (IHS) invites the 

general public to take this opportunity 

to comment on the information 

collection Office of Management and 

Budget (OMB) Control Number 0917– 


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